Chronic PeriodontitisNCT03923829
The Effect of Zinc on the Gingival Crevicular Fluid Level of Total Oxidant Capacity in Type 2 Diabetic Patients
A study testing Zinc Sulfate and scaling and root planing in people with Chronic Periodontitis, run by Cairo University.
Trial summary
To evaluate the effect of systemic administration of zinc on the gingival crevicular fluid level of total oxidant capacity in controlled Type-2 diabetic patients with stage-II and III periodontitis after non-surgical periodontal therapy. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Zinc Sulfate and scaling and root planing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2019to 30 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Controlled Type-2 diabetes mellitus
- Stage-II \&III periodontitis
- At least 2 sites with clinical attachment loss 3 or 4 mm to ≥5 mm and radiographic bone loss 15% Extending to mid-third of root and beyond.
- Probing depth from ≤5 mm to ≥6 mm
Who cannot join
- Any periodontal or Antibiotic treatment during the last six months.
- Receiving trace element supplements in the previous three months
- Pregnant or lactating females
- Gastric or diuretic treatment
- Acute renal failure
- smoking
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Systemic Administration of Zinc on the Gingival Crevicular Fluid Level of Total Oxidant Capacity in Type 2 Diabetic Patients With Stage II and III Periodontitis After Non-surgical Periodontal Therapy
To evaluate the effect of systemic administration of zinc on the gingival crevicular fluid level of total oxidant capacity in controlled Type-2 diabetic patients with stage-II and III periodontitis after non-surgical periodontal therapy.
Read the detailed description
Hypozincaemia and hyperzincuria is known to be present in patients with type-2 diabetes, and Zinc supplementation is known to be helpful in restoring plasma Zinc levels to normal,Zinc's deficiency can lead to an increase in circulating glucose due to beta cells malfunctioning and resistance to insulin, which makes it easier for type 2 diabetes mellitus (DM2) to happen ,Zinc was found to be a structural part of key anti-oxidant enzymes such as superoxide dismutase (SOD), and Zinc deficiency impaired their synthesis, leading to increased oxidative stress
- Conditions
- Chronic Periodontitis
- Being tested
- Zinc Sulfate, scaling and root planing
- Keywords
- zinc, Non-surgical Periodontal Therapy, stage II periodontitis, stage III periodontitis, gingival crevicular fluid, total oxidant capacity, Type 2 diabetic patients
- Medical subject headings
- Chronic Periodontitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc SulfateDrug
Also called Zinc Sulfate with scaling and root planing
systemic administration of Zinc sulfate with scaling and root planing
scaling and root planingProcedure or surgery
scaling and root planing
| Study group | Role | What they receive |
|---|---|---|
| Zinc administration with scaling and root planing | Experimental | systemic administration of Zinc cap of 50 mg elemental zinc as zinc sulphate, once a day for 12 weeks in addition to scaling and root planing Receives: Drug: Zinc Sulfate |
| scaling and root planing | Active comparator | scaling and root planing Receives: Procedure: scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline Hb-A1c
Measured: change from baseline Hb-A1c at 3 monthes
Secondary outcomes (4)
Hb-A1c
Hb-A1c
Measured: at the baseline and after 3 months
Probing pocket depth
Probing pocket depth Measured as the distance between the gingival margin and the apical part of the pocket will be measured using William's graduated periodontal probe.
Measured: at the baseline and after 3 months
Clinical attachment level
It will be measured from the cemento-enamel junction till the apical part of the pocket.
Measured: at the baseline and after 3 months
Gingival index
Gingival Index for a specific tooth == Average (points for the 4 surfaces)
Measured: at the baseline and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start30 Apr 2019 (estimated)
- Primary completion30 Aug 2020 (estimated)
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulrahman Abdulqawi Awadh Abdulrab, Cairo University
- Investigators
- Dr. Enji Ahmed, professor, Principal investigator, Cairo UniversityDr. weam elbattawy, Lecturer, Study director, Cairo UniversityDr. Ollfat Shaker, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923829
- Sponsor's protocol ID
- 6653486
- Status last verified
- Apr 2019
- First submitted
- 17 Apr 2019
- Last updated
- 23 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khan MI, Siddique KU, Ashfaq F, Ali W, Reddy HD, Mishra A. Effect of high-dose zinc supplementation with oral hypoglycemic agents on glycemic control and inflammation in type-2 diabetic nephropathy patients. J Nat Sci Biol Med. 2013 Jul;4(2):336-40. doi: 10.4103/0976-9668.117002.
PubMed 24082728Thomas B, Prasad RB, Shetty S, Vishakh R. Comparative Evaluation of the Lipid Profile in the Serum of Patients with Type II Diabetes Mellitus and Healthy Individuals with Periodontitis. Contemp Clin Dent. 2017 Jan-Mar;8(1):96-101. doi: 10.4103/ccd.ccd_1160_16.
PubMed 28566858
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Systemic Administration of Zinc on the Gingival Crevicular Fluid Level of Total Oxidant Capacity in Type 2 Diabetic Patients With Stage II and III Periodontitis After Non-surgical Periodontal Therapy
- ClinicalTrials.gov ID
- NCT03923829
- Acronym / sponsor ID
- 6653486
- Conditions
- Chronic Periodontitis
- Keywords
- zinc, Non-surgical Periodontal Therapy, stage II periodontitis, stage III periodontitis, gingival crevicular fluid, total oxidant capacity, Type 2 diabetic patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Apr 2019 (estimated)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effect of systemic administration of zinc on the gingival crevicular fluid level of total oxidant capacity in controlled Type-2 diabetic patients with stage-II and III periodontitis after non-surgical periodontal therapy.
Detailed description
Hypozincaemia and hyperzincuria is known to be present in patients with type-2 diabetes, and Zinc supplementation is known to be helpful in restoring plasma Zinc levels to normal,Zinc's deficiency can lead to an increase in circulating glucose due to beta cells malfunctioning and resistance to insulin, which makes it easier for type 2 diabetes mellitus (DM2) to happen ,Zinc was found to be a structural part of key anti-oxidant enzymes such as superoxide dismutase (SOD), and Zinc deficiency impaired their synthesis, leading to increased oxidative stress
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zinc administration with scaling and root planing | Experimental | Drug: Zinc Sulfatesystemic administration of Zinc cap of 50 mg elemental zinc as zinc sulphate, once a day for 12 weeks in addition to scaling and root planing |
| scaling and root planing | Active comparator | Procedure: scaling and root planingscaling and root planing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Controlled Type-2 diabetes mellitus
- Stage-II \&III periodontitis
- At least 2 sites with clinical attachment loss 3 or 4 mm to ≥5 mm and radiographic bone loss 15% Extending to mid-third of root and beyond.
- Probing depth from ≤5 mm to ≥6 mm
Key exclusion criteria (6 listed)
- Any periodontal or Antibiotic treatment during the last six months.
- Receiving trace element supplements in the previous three months
- Pregnant or lactating females
- Gastric or diuretic treatment
- Acute renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc SulfateAlso: Zinc Sulfate with scaling and root planingsystemic administration of Zinc sulfate with scaling and root planing | Drug | Zinc administration with scaling and root planing |
| scaling and root planingscaling and root planing | Procedure or surgery | scaling and root planing |
Primary outcome
change from baseline Hb-A1c
Time frame: change from baseline Hb-A1c at 3 monthes
4 secondary outcomes
Hb-A1c
Time frame: at the baseline and after 3 months
Probing pocket depth
Time frame: at the baseline and after 3 months
Clinical attachment level
Time frame: at the baseline and after 3 months
Gingival index
Time frame: at the baseline and after 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Results publication: PubMed 24082728Khan MI, Siddique KU, Ashfaq F, Ali W, Reddy HD, Mishra A. Effect of high-dose zinc supplementation with oral hypoglycemic agents on glycemic control and inflammation in type-2 diabetic nephropathy patients. J Nat Sci Biol Med. 2013 Jul;4(2):336-40. doi: 10.4103/0976-9668.117002.
- Results publication: PubMed 28566858Thomas B, Prasad RB, Shetty S, Vishakh R. Comparative Evaluation of the Lipid Profile in the Serum of Patients with Type II Diabetes Mellitus and Healthy Individuals with Periodontitis. Contemp Clin Dent. 2017 Jan-Mar;8(1):96-101. doi: 10.4103/ccd.ccd_1160_16.
Related trials for Chronic Periodontitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Effect of Cyperus Articulatus on Bacterial Reduction and Postoperative Pain
Chronic Apical Periodontitis
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
RecruitingObservational study
Evaluation of Masticatory Performance in Patients With Periodontitis
Periodontitis, Adult, Periodontitis
Recruiting
Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
Single-visit, Periapical Periodontitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Enji Ahmed, professor principal investigator
Cairo University
Dr. weam elbattawy, Lecturer study director
Cairo University
Dr. Ollfat Shaker, professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Zinc Sulfate and scaling and root planing in people with Chronic Periodontitis, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact abdulrahman A Abdulrab (+201014624724, abdulrahman.awadh@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline Hb-A1c (time frame: change from baseline Hb-A1c at 3 monthes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03923829, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.